Trial · NCT01342952
Outcomes56
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 56
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Non-serious Treatment-emergent Adverse Events (Non-STEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Up to 10 years and 11 months | Safety Population consisted of all participants who received at least 1 dose of study drug. Participants were considered as belonging to the treatment group according to the highest dose received in the extension study (AMB114588) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Liver Function Parameters: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Total Bilirubin | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Millimoles per liter | MEAN |
| PRIMARY | Change From Baseline in Chemistry Parameters: Calcium, Chloride, Carbon Dioxide (CO2) Content, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Blood Urea Nitrogen (BUN) | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Millimoles per liter | MEAN |
| PRIMARY | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Creatine Kinase (CK), Lactate Dehydrogenase (LDH) | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | International units per Liter | MEAN |
| PRIMARY | Change From Baseline in Chemistry Parameters: Creatinine, Uric Acid | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Micromoles per liter | MEAN |
| PRIMARY | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Grams per liter | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Grams per Liter | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Hematocrit | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Proportion of red blood cells in blood | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC), Platelet Count | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Giga cells per Liter | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Picograms | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter: Mean Corpuscle Volume | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Femtoliters | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Red Blood Cell Count, Reticulocytes | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Trillion cells per liter | MEAN |
| PRIMARY | Number of Participants With Abnormal Values for Physical Examination Parameter: Liver Size | Up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Values for Physical Examination Parameter: Jugular Venous Pressure | Up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Values for Physical Examination Parameters: Ascites | Up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Values for Physical Examination Parameter: Peripheral Edema | Up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Saturated Oxygen Level (Physical Examination Parameter) | Up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Percentage of oxygen saturation | MEAN |
| PRIMARY | Change From Baseline in Vital Signs Parameter: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Millimeters of mercury | MEAN |
| PRIMARY | Change From Baseline in Vital Signs Parameter: Heart Rate | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Beats per minute | MEAN |
| PRIMARY | Change From Baseline in Vital Signs Parameter: Weight | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Kilograms | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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